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Clinical Research Associate Ii (Client Base, Mumbai Location)

3+ years
Not Disclosed
10 Nov. 11, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Research Associate II — Structured Job Description

Position Details

  • Role: Clinical Research Associate II (Client-Based)

  • Location: Mumbai, India

  • Company: Syneos Health

  • Job ID: 25102785

  • Updated On: 4 November 2025


About Syneos Health

Syneos Health is a fully integrated biopharmaceutical solutions organization supporting clinical development, medical affairs, and commercial operations. With 29,000 employees across 110+ countries, the company focuses on accelerating the development and delivery of life-changing therapies through innovation, collaboration, and a strong patient-first approach.


Why Work at Syneos Health

  • Career development and growth pathways

  • Supportive line management & technical training

  • Total Rewards Program

  • Strong culture of inclusion (Total Self Culture)

  • Diverse global workforce that fosters belonging


Required Qualifications

  • Bachelor’s degree in Life Sciences or related field

  • 3+ years of relevant clinical research experience

  • Minimum 1 year of monitoring experience (mandatory)

  • Strong knowledge of:

    • ICH-GCP guidelines

    • Local regulatory requirements

    • Clinical trial processes

  • Strong time management & organizational skills

  • Ability to build strong site relationships under pressure

  • Excellent communication & interpersonal skills

  • Good computer literacy and adaptability to new technologies

  • Willingness to travel up to 75%


Preferred Qualifications

  • Experience in Pharma/Biotech sponsor roles

  • Experience as a Clinical Study Coordinator

  • 3+ years monitoring experience (preferred)

  • Understanding of medical settings, medical records & investigator site processes


General Role Description

CRA II is responsible for overseeing the progress of clinical trials to ensure:

  • Compliance with protocol

  • Adherence to SOPs

  • Alignment with GCP and regulatory requirements

  • Quality and integrity of data collected
    Acts as a point of contact for clinical trial sites and ensures smooth site operations.


Core Responsibilities

1. Site Identification & Feasibility

  • Identify new potential investigators

  • Assess site capabilities & resources

  • Recommend suitable sites during feasibility

2. Pre-Study & Initiation

  • Conduct pre-study visits

  • Perform site initiation visits

  • Deliver protocol-specific training to site personnel

3. Monitoring & Site Management

  • Conduct on-site & remote monitoring visits

  • Ensure subject safety & protocol compliance

  • Verify source documents & data accuracy (SDV/SDR)

  • Maintain eCRF data availability

  • Use risk-based monitoring to detect issues

  • Perform unblinded monitoring when required

  • Document findings and escalate issues appropriately

  • Train and support site staff regularly

4. Issue Resolution & CAPA

  • Identify issues proactively

  • Support sites in implementing corrective & preventive actions

  • Participate in regulatory audits/inspections

5. Study Close-Out

  • Perform site closure when all visits are completed

  • Ensure all essential documents and follow-ups are finalized

6. Additional Support Activities

  • Ethics Committee submissions (if required)

  • Assistance in ICF reviews

  • Coordination of system access for sites (eDC, vendor platforms)

  • Tracking equipment calibration

  • Supporting preparation of Study Initiation materials

  • Supporting database lock timelines


Summary of Role Impact

  • Ensures clinical trials run smoothly, ethically, and compliantly

  • Monitors data integrity using remote/onsite techniques

  • Works cross-functionally to improve trial efficiency

  • Contributes to process improvements and study quality

  • Acts as an established individual contributor with potential to manage small components or junior staff